Regulatory affairs folks had little time to relax in 2013, with heated debates over the future of EU device regulations, new controls in Japan and a proposed regulatory framework in India. And that’s just the tip of things. During the year, Malaysia got busy implementing its new device law and Brazil eased the process for device registration. Members of the International Medical Device Regulators Forum cemented plans for a January launch of a single-audit pilot program, and the U.S. Food and Drug Administration finalized rules for unique device identification. Use this review to reflect on developments in 2013 and prepare a winning business strategy in 2014. Read More

Racer Technology, a Singapore maker of cochlear implant accessories, expressed confusion about the term “device history record” during a recent FDA inspection, drawing a warning letter from the agency. Read More

Invacare says it has made “significant progress” on its FDA consent decree, but must do some additional work on its complaint system before an independent auditor provides final certification to the agency. Read More

Abbott Laboratories has agreed to pay the U.S. government nearly $5.5 million to settle Medicare fraud and kickback claims. Read More

Synecco, a China-based contract manufacturer and contract sterilizer, received an FDA warning letter for shortfalls in sterilization validation and other GMP issues. Read More

San Up, a Buenos Aires maker of piston and ultrasonic nebulizers, was warned by the FDA after cleaning shortfalls and other good manufacturing practice slip-ups. Read More

CAPA shortfalls identified during an FDA inspection in late August and September led to a recent Form 483 for Teleflex Medical. Among noted deviations, the company did not evaluate whether it should initiate a CAPA for distributed humidifier adaptor devices with seal defects. Read More

Lucero Medical, maker of the Enduramesh Corpectomy Spacer System, lacks design validation for the device, despite implantation of 89 of the vertebral body replacement systems by the time of an FDA inspection, according to a recent Form 483. Read More

GE Medical Systems received a post-inspection Form 483 after failing to create a CAPA record for an observation from a previous inspection. Read More

While all FDA device investigators go through specialized training, combination products and foreign inspections can still pose challenges during the inspection process. Read More

The FDA will soon begin identifying candidates for a pilot program that will let manufacturers self-identify and correct possible regulatory violations to avoid FDA inspection. Read More